A Phase 4 Open-Label Study Evaluating Valbenazine for Adults with Tardive Dyskinesia Remaining Symptomatic on or After VMAT2 Inhibitor Treatment

What this Trial Is About

Researchers are evaluating the effectiveness of valbenazine in adults with tardive dyskinesia (TD) who continue to have symptoms while taking or after stopping a vesicular monoamine transporter 2 (VMAT2) inhibitor. This Phase 4 open-label study focuses on both clinician- and patient-reported outcomes to better understand valbenazine's impact on TD symptoms in participants with schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder. Participants will receive oral valbenazine capsules once daily for 24 weeks. The study monitors changes in involuntary movement using the Abnormal Involuntary Movement Scale (AIMS) and evaluates other measures related to disease severity and quality of life. This open-label treatment period allows all participants to receive the study drug without placebo comparison. During the study, participants will undergo assessments at baseline and Week 24 including movement evaluations, clinical global impression scores, and patient-reported impact and health-related quality of life scales. Researchers will track safety and tolerability throughout the 24-week treatment. Total participation time corresponds to the 24 weeks of daily valbenazine treatment and follow-up assessments.

A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor